Drainage device



Nov. 19, 1963 R. R. scHULTE DRAINAGE DEVICE Filed Nov. 6, 1961 UnitedStates Patent O 3,111,125 DRAFLNAGE DEJECE Rudolf R. Schutte, 16 WadeCourt, Santa Barbara, Calif.

Filed Nov. n, 1962i, Ser. No. 156,272 18 Claims. (Ci. 12S-350) Thisinvention relates to a diaphragm-type pump, and to conduit means whichcan be associated therewith to form shunt connections with various partsof the human body to relieve one of said parts of undesirableaccumulations of uids.

`in the medical iield, there is a standing requirement for small andreliable diaphragm pumps which can be installed in body cavities, and beused for ilushing purposes. As a single example, the ailment known ashydrocephalus involves the complication that fluids which ought to drainaway accumulate within the skull where they exert excruciating pressureand sku'll-deforming forces. Draining these iluids by means such as thedevice shown in United States Patent No. 2,969,066- issued lanuary 24,1961, relieves the symptoms and frees the individual from the terribleconsequences of the iluid accumulation by draining away the i'luid.However, conventional methods of treatment of hydrocephalus by drainagehave often utilized components which tended to become obstructed byparticulate matter entering the drainage system, or by the backwarddiffusion of blood into the system.

The difficulties inherent in conventional drainage devices can be curedby providing a flushing pump which is capable of overcoming both thetendencies -to clog and to diiiuse backwardly. Conventional diaphragmpumps are not suitable for this type of pump, because it has been foundthat sometimes when the diaphragm is pressed down, it will adhere to thewall of the pump cavity and will not spring back. Then the pump itselfclogs the drain, and adds to the malfunction which it is provided toobviate. Furthermore, since the pump is not external to the body, butrather is installed under the skin, in order to repair or manipulate itto reopen the same, it is necessary to undergo extensive and carefulsurgical procedures which ought to be avoided. Furthermore, conventionaldiaphragm pumps ordinarily utilize ytwo check valves, thereby increasingthe complexity of the device.

This invention has as its objective the provision of a diaphragm-typepump which requires only one check valve, which check valve is the oneprovided on the drain pump anyway, and the sole moving part of which, adiaphragm, is so disposed, arranged and designed that it cannot possiblyfreeze in any position at all, including the position corresponding toadhesion with the pump cavity wall.

A further object of this invention is to provide a pump together with acheek tube, which in combination provides means for draining andpositively discharging, in unidirectional iiow, accumulated undesiredfluids from body cavities.

A diaphragm pump according to this invention includes a body which has awall defining an internal cavity. A diaphragm extends across this cavityand divides it into a iirst and second chamber. An inlet port extendsthrough the wall and opens into the first chamber, while an outlet portextends through the wall and opens into the second chamber. There is animperforate area on the diaphragm which is so disposed and arranged as`to be contactible with the inlet port to close it in one of thediaphragm positions and to move away from it to leave the inlet portopen in another of the diaphragm positions.

The diaphragm is provided with an open passage therethrough `which isdisposed outside the imperforate area and which places the two chambersin constant fluid ICC communication. The wall of the body has a flexibleportion in at least one part of the wall which bounds the second chamberso that force can be exerted in the second chamber for moving theimperforate area of the diaphragm to close the inlet port and to pumpiiuid out or" both chambers by the force exerted. Fluid from the firstchamber passes through the passage in the diaphragm to get into thesecond chamber, and thence tiows through the outlet por-t.

According to a preferred but optional feature of the invention, a crownsurrounds the inlet port inside the first chamber and extends into it inorder to prevent the imperforate areas making contact with the wallimmediately adjacent to the inlet port where it might occasionally occurthat a reverse pressure, combined with surface adhesion properties,could tend to hold the diaphragm firmly and permanently against thewall, thereby requiring the removal and replacement of the pump.

According to another preferred but optional feature of the invention, acheck tube is connected to the outlet port of the diaphragm pump toprovide for a uid conduit system for accomplishing the objectives of theinvention.

IWhile the device of the invention may be made of any one of a number ofconventional materials, it is preferably made of silicon rubber. Such amaterial provides the necessary transparency and flexibility of thestructure, while being a material which is essentially inert to the bodyiiuids.

The invention may be more readily understood by referring to theaccompanying drawings in which:

FIGURE l is a pictorial representation of a small child, illustratingthe placement of the apparatus according to the invention;

FIGURE 2 is an exploded perspective view of a diaphragm pump of thepresent invention;

`FIGURE 3 is a sectional View of the device of FIG. 2 as disposed inuse;

FEGURE 4 is a sectional view of the diaphragm pump of this invention inuse and being flushed by an attendant; and

FIGURE 5 is a partial sectional view of the check tube termination ofthe apparatus illustrating the disposition of the outlet slits.

Referring now to FIG. 1, there is shown a small child lil having a headand a heart, between which is disposed a ventrculo-atrial shuntapparatus 11. The ventrculoatrial shunt apparatus .11 includes an inlettube 12 shown in dotted lines, extending from a pump 13I into thecranial cavity of the head, and an outlet tube 14 (sometimes hereincalled a check tube) extending between the valve 13 and the atriumportion of the heart, through the childs jugular vein 15. rhe pump 13 isheld in place in a small burr hole (not shown) in the skull of the childby means of a tlap of skin sho-wn as sewn in place by stitches.

In FIG. 2 the pump 13 is seen to consist of an upper member 16 and alower member 17, within which is disposed a perforate diaphragm 1Shaving apertures 19' extending therethrough. A tube or conduit forms anoutlet port Zd and fits between a irst recess 21 in the lower member anda second recess 21 in the upper member. The lower member 17 has an inletconduit 22 extending thereinto about the opening of which is formed ashoulder 23.

The central portions of the lower surface of uppermember 16 and of theupper surface of lower member 17 form a wall defining a cavity therein.The diaphragm divides the cavity into a iirst and a second chamber. Thefirst chamber is formed between the diaphragm and that portion of thewall formed by lower member 17. The second chamber is formed between thediaphragm and that portion of the wal'l formed by upper member 16.

animas At least a portion of one of these walls is exible, and in theembodiment illustrated, a portion of the wall bounding the secondchamber is more ilexible than that bounding the iirst chamber. Inletport 24 (sometimes called inlet conduit opening) opens into the rstchamber at a central location. Apertures 19 (sometimes herein calledpassages) are laterally placed relative to the inlet port so that theydo not overlay it. This leaves a central imperforate diaphragm areawhich can move down to close the inlet port.

Referring now to FIG. 3, there is shown the pump 1.3 in place in thehuman body. The upper and lower members 16 and 17 may be held togetherby Iany conventional adhesive means so as to fonm the capsular enclosuretherebetween. The pump has been inserted in a burr hole, indicatedgenerally at Sil, which has been cut through the skull bone 31 of thechild. A flap of skin 32 overlies the apparatus.

As shown, the members 16 and 17 are curved in configuration so as toform a hollow enclosure within which the diaphragm `1S is disposed. Itwill be noted that the diaphragm 18 is held in position by -means of aninner projecting ring 35 formed in the lower member 17. O-f course, ifdesired, the ring 35 can be formed in the upper member 16. The pump 13has an outer peripheral ilange portion 36 formed by both the upper andlower members 16 and 17, which assists in holding the device in positionby providing la portion through which ligatures may be threaded and sewninto the surrounding ilesh.

The burr hole 36 is filled with body fluid 3,8, which is not the uid ofinterest in the treatment of hydrocephalus.

VThe cerebral spinal Ifluid (not shown) is drained from the cranialcavity, enters the inlet tube 12 (see FIG. 1), and passes through theinlet conduit -22 into the portion of the pump 13 beneath the diaphragm18 as shown by the arrows. Due to the slight pressure dilferentialexisting between the cranial cavity and heart, the fluid then passesthrough the apertures I19 in the perforate diaphragm 18 and into theupper portion of the enclosure. The Huid may then pass through theoutlet port 2t) and into the check tube .1 through a connector 39, towhich the conduit iil and check tube '15 are tied by ligatures 40, forexample. The conduit 22 is similarly connected to the tube 12.

In FIG. 4, the device of FIG. 3 is shown while being hushed. Flushing isaccomplished by pressure, as by a linger 41, upon the upper portion ofthe enclosure 13. Since ythe pump 13 is filled with lluid, this pressureforces the diaphragm 1-8 against the raised shoulder 23 (sometimescalled a crown) surrounding the inlet conduit 22 so as to close theinlet conduit opening 24. This increased pressure is applied thereforeonly to the fluid already within the enclosure Iand in the outlet tube.This fluid is then forced through the outlet tube and out of theopenings therein so as to clean out any particulate material or bloodwhich may be in the outlet tube causing blockage.

In FIG. 5 the termination `and slit valve of the check tube 1'4 lareshown. It lwill be seen that the termination consists of a solid taperedportion yl5 and the slit valve of a plurality of slits 46 (three beingshown in FIG. 5). These slits are preferably about one-sixteenth inch inlength, and four of them are formed in the tubing in the preferredembodiment by cutting the slits in the tubing `without removing anymaterial therefrom. The use of such a multiple slit valve in the outlettube permits cerebral spinal fluid to llow `freely when the pressure inthe tube exceeds six to ten centimeters of water, while remaining closedat a lower pressure. This structure also reduces t-he tendency of bloodto diifuse into the outlet end and cause its obstruction. The operationof the outlet slit valve structure is readily checked by filling theoutlet tube with sterile physiological saline solution, while holdingthe tube in vertical position. In a period of from thirty to sixtyseconds, the height of iiuid in the l outlet tube should diminish to sixto ten centimeters from the top of the slit valve.

The tubing itself is conventional tubing of preferably one-sixteenthinch in diameter and one-sixtyafourth inch wall thickness. The capsularenclosure is comparatively small so as to iit in a burr hole of sixteento eighteen millimeters diameter, the iiange extending out over theedges of the hole so as to overlie the surrounding skull. The enclosuremay have a Wall thickness, for example, of one-thirty-second of an inch.The diaphragm at its central portion is preferably from three to vethousandths of an inch in thickness in order to provide the requisiteflexibility. The silicon rubber is comparatively flexible so as topermit 'facile ilushing of the device, as has been previously described.

The surgical technique for utilization of the apparatus will now bedescribed. Two incisions are required; a small scalp flap in theposterior temporal region and a diagonal incision crossing the anterioredge of the sternomastoid muscle lat the angle of the jaw. The posteriortemporal burr hole is located in a manner Ithat allows the tube to curvegently without kinking as it emerges from the lateral `ventricle andpasses subcautaneously into the neck.

A standard trephine opening, sixteen to eighteen millimeters indiameter, is made. The dura is incised in a cruci-ate manner. Aventricular cannula is passed into the lateral ventricle and immediatelywithdrawn so that only a minimal amount of cerebrospinal fluid escapes.The ventricular component of the shunt is then immediately inserted intothe cannula tract and directed into the lateral ventricle. At least fivecentimeters to eight centimeters of the tube should lie within thelateral ventricle. A small amount of cerebrospinal fluid is permitted toescape from the tube. This maneuver assures the operator that the fluidis clear and colorless, and that the tube is unobstructed by brainfragments. This tube is then occlvuded with a small bulldog clamp,applied just beyond the point of emergence ffrom the dura. Every effortshould be made to prevent the loss of centricular lluid so that when theends of the shunt are joined it will be set in operation by asatisfactory pressure. The dura is closed tightly 4around the tube withnon-absorbable sutures.

The incision in the neck is made at the point overlying the entrance ofthe common facial vein into the internal jugular vein. This vein entersthe jugular vein on its mesial aspect at the level of the hyoid bone.Even in young infants this vessel is sufciently large to permit passageof the cardiac end of the shunt. The common facial vein is preferred,but when its use is not practical, a similar vein or even the internaljugular vein may be used. 'After dissecting the vein free of thesurrounding tissue, two 3 0 silk ligatures are placed beneath it. Atthis point, the cardiac segment of the shunt is prepared for insertion.The distance from the suprasternal notch up to the point at which thetube will enter the jugular vein is added to the pre-operativemeasurement from the suprasternal notch to the fifth and sixth dorsalvertebral interspace. This distance is marked on the tube by tying aligature around it, care being taken not to occlude the lumen of thetube. The tube is then filled With physiological saline leaving thesyringe attached to it. The common yfacial vein is then stretchedbetween the two ligatures and incised with the iris scissors. While theslit is held open with fine mouse-tooth forceps held by the surgeon andhis assistant, the tapered end of the tube containing the valve ispassed into the lumen and directed down the internal jugular vein intothe right atrium. The tip of the tube should be located in the rightatrium `at the level of the fifth or sixth dorsal 'vertebral bodies. Theligature on the common `facial vein proximal to the jugular vein isrelaxed as the tube passes this point. Since this tube completely iillsthe lumen of the vessel, there is no danger of air embolism. Two

milliliters of contrast medium (Renografin, Hypaque) are then injectedinto the tube, and an X-ray is made. Adjustments in the position of thevalve in the right atrium can now be made, depending on the indicationof the X-ray film. When properly located, the ligature surrounding thecommon facial Vein containing the shunt is tied snugly but not sotightly as to occlude the tube. The other ligature on the common facialvein is tied tightly and the vessel is divided. The contrast medium isthen flushed from the tube with physiological saline.

The final step is the attachment of the ventricular and cardiac tube tothe diaphragm pump. Care should be taken not to puncture the capsulewhile placing securing ligatures through the flange. These ligatures areused to fasten the flange to either the skull or pericranium. Theoperation of the fiushing device should be checked before closing thewounds.

The invention claimed is:

`1. A diaphragm pump for use in draining fiuid from one portion of ahuman body and transferring it to another portion of the body comprisinga capsular enclosure, at least the upper portion of which is iiexible,an outlet conduit formed in the upper portion of the enclosure andopening thereinto, an inlet conduit formed in the lower portion of theenclosure and opening thereinto, a raised shoulder formed on the innersurface of the lower portion about the inlet opening, a iiexiblediaphragm disposed within the enclosure, and means holding the diaphragmwithin the enclosure so as to separate the upper portion from the lowerportion thereof, said diaphragm having an aperture extendingtherethrough, said aperture being disposed so as to be out of alignmentwith the inlet opening.

2. Fluid-conducting shunt apparatus comprising an inlet tube, an outlettube, a capsular enclosure of fiexible material, a diaphragm disposedwithin the capsular enclosure and held therewithin, an outlet conduitextending through the enclosure and opening onto one side of thediaphragm, an inlet conduit extending through the enclosure and openingonto the other side of the diaphragm, a raised shoulder formed on theinner surface of the enclosure about the inlet conduit opening, saiddiaphragm having an aperture extending therethrough and disposed so asto be out of alignment with the inlet conduit opening, an imperforateregion on said diaphragm in alignment with the inlet conduit openingadapted to close said opening in one position of the diaphragm, meansconnecting the outlet conduit to the outlet tube so as to form a fluidconduit therethrough, and means connecting `the inlet conduit to theinlet tube so as to form a iiuid conduit therethrough.

3. Apparatus according to claim 2 in which the outlet tube terminationremote from the enclosure is a solid tapered end and has a plurality oflongitudinally disposed outlet slits formed therein adjacent the solidend.

4. Apparatus according to claim 3 in which the enclosure and diaphragmare made of silicone rubber,

5. A diaphragm pump comprising: a body having a wall defining aninternal cavity; a diaphragm extending across the cavity and dividing itinto a rst and a second chamber; an iniet port through the wall openinginto the first chamber; an outlet portion through the wall opening intothe second chamber; an imperforate area on the diaphragm so disposed andarranged as to be contactable with the inlet port to close it in onediaphragm position, and to move away from it to leave the inlet portopen in another diaphragm position, the diaphragm also having an openpassage therethrough disposed outside the imperforate area and placingthe two chambers in constant fluid communication; and a iiexible portionin at least part of the wall which bounds the second chamber, wherebyforce applied externally to the flexible portion moves the imperforatearea to close the inlet port and applies pressure to expel fluid throughlthe outlet port, fluid from the first chamber flowing into the secondchamber through the passage, `and from the second chamber into theoutlet port, release of the flexible wall portion enabling the diaphragmto move away from the inlet port, the diaphragm pump then permittingsubstantially unimpeded passage of Huid from inlet port to outlet portthrough the passage in the diaphragm.

6. A diaphragm pump according to claim 5 in which the wall of one of thechambers is less liexible than the wall of the other chamber.

7. A diaphragm pump according to claim 5 in which a crown surrounds theinlet port inside the first chamber and extends into the first chamberto prevent the imperforate areas making contact fwith the wallimmediately adjacent to the inlet port.

8. A diaphragm pump according to claim 7 in which the pump in plan viewis generally symmetrical around an axis, with the inlet port,imperforate area, and flexible wall portion centered on said axis, andwith the outlet port at one side thereof.

9. A diaphragm pump according to claim 8 in lwhich a peripheralinstallation flange is attached to the body.

10. A diaplnagm pump comprising: a body having a wall defining aninternal cavity; an internal flange extending peripherally around `thewall; a diaphragm retained by the internal flange and extending acrossthe cavity to divide it into a first and a second chamber, a flexible,imperforate diaphragm area at a medial region of the diaphragm, and aheavier-sectioned reinforcing bead portion `surrounding said iiexiblearea and joining to the wall at the internal flange, said diaphragm alsohaving an open passage therethrough which places the two chambers inconstant fluid communication; an inlet p-ort through the wall openinginto the first chamber; an outlet port opening through the wall into thesecond chamber, at least a part of the imperforate diaphragm area beingso disposed and arranged as to be contactible with the inlet port toclose it in one diaphragm position, and to move away from it to leavethe inlet port open in another diaphragm position, the passage lyingoutside the imperforate diaphragm area; and a flexible portion in atleast part of the wall which bounds the second chamber, whereby forceapplied externally to the flexible portion moves the imperforate area toclose the inlet port and applies pressure to expel fluid through theoutlet port, fluid owing from the first chamber into the second chamberthrough 'the passage, and from the second chamber into the outlet port,release of the flexible rwall portion enabling the diaphragm to moveaway from the inlet port, the diaphragm pump `then permittingsubstantially unimpeded passage of fluid from inlet port to outlet portthrough the passage in the diaphragm.

11. A diaphragm pump according to claim 10 in which the wall of one ofthe chambers is less flexible than the wall of the other chamber.

l2. A diaphragm pump according to claim 11 in which the less flexiblewall is that of the first chamber.

13. A diaphragm pump according to claim 10 in which a crown surrroundsthe inlet port inside the first chamber and extends into the firstchamber to prevent the imperforate areas making contact with the wallimmediately adjacent to the inlet port.

14. A diaphragm pump according to claim 13 in which the pump in planView is generally symmetrical around an axis, with `the inlet port,imperforate area, and fiexible wall portion centered on said axis, andwith the outlet port at one side thereof.

15. A diaphragm pump according to claim 14 in which a peripheralinstallation fiange is attached to the body.

16. In combination: a drain tube having openings to admit fluid thereto;a check tube having unidirectional liow check means for permitting flowonly in a first direction; a diaphragm pump comprising: a body having awall defining an internal cavity; a diaphragm extending across thecavity and dividing it into a first and second chamber; an inlet portthrough the wall opening into the irst chamber; an outlet port throughthe wall opening into the second chamber; an imperforate area on thediaphragm so disposed and arranged as to be contactible with the inletport to close it in one diaphragm position, and to move away from it toleave the inlet port lopen in another diaphragm position, the diaphragmalso having an open passage therethrough disposed outside theimperforate area and placing the two chambers in constant fluidcommunication; and a iiexible portion in at least part of `the wallwhich bounds the second chamber, whereby force applied externally to theflexible portion moves the imperforate area to close the inlet port andapplies pressure to expel fluid through the outlet port, fluid flowingfrom the rst chamber into the second charmber through the passage, andfrom the second chamber into the outlet port, release of the flexiblewall portion enabling the diaphragm to morve away from the inlet port,the diaphragm permitting substantially unimpeded passage of fluid frominlet port to outlet port through the passage; said drain tube beingconnected to the inlet port, and the check tube being connected to theoutlet port with said iirst ow direction being away from the outletport, whereby steady drainage from the drain tube through the pump andout the check tube is possible through the diaphragm passage, and pumpedflow in the same direction is causable by exerting force on the llexiblewall portion.

17. A combination according to claim 16 in which a crown surrounds theinlet port inside the first chamber and extends into the -rst chamber toprevent the imperforate areas making contact with the wall immediatelyadjacent to the inlet port.

18. A combination according to claim 16 in which the wall of the `firstchamber is less iiexible than the wall of the second chamber.

References Cited in the le of this patent UNITED STATES PATENTS2,758,609 Dickert et a1 Aug. 14, 1956 20 2,867,213 Thomas Jan. 6, 19592,969,066 Holter et al Ian. 24, 1961

1. A DIAPHRAGM PUMP FOR USE IN DRAINING FLUID FROM ONE PORTION OF AHUMAN BODY AND TRANSFERRING IT TO ANOTHER PORTION OF THE BODY COMPRISINGA CAPSULAR ENCLOSURE, AT LEAST THE UPPER PORTION OF WHICH IS FLEXIBLE,AN OUTLET CONDUIT FORMED IN THE UPPER PORTION OF THE ENCLOSURE ANDOPENING THEREINTO, AN INLET CONDUIT FORMED IN THE LOWER PORTION OF THEENCLOSURE AND OPENING THEREINTO, A RAISED SHOULDER FORMED ON THE INNERSURFACE OF THE LOWER PORTION ABOUT THE INLET OPENING, A FLEXIBLEDIAPHRAGM DISPOSED WITHIN THE ENCLOSURE, AND MEANS HOLDING THE DIAPHRAGMWITHIN THE ENCLOSURE SO AS TO SEPARATE THE UPPER PORTION FROM THE LOWERPORTION THEREOF, SAID DIAPHRAGM HAVING AN APERTURE EXTENDINGTHERETHROUGH, SAID APERTURE BEING DISPOSED SO AS TO BE OUT OF ALIGNMENTWITH THE INLET OPENING.